Effects of Yoga Therapy in Rehabilitation Compared to Physiotherapy in Moderate Axial Spondyloarthritis (axSPA)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Yogatherapy, Physiotherapy.
- Кому может быть актуально
- Состояния в реестре: Axial Spondyloarthritis (axSPA). Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Effects of Yoga Therapy in Rehabilitation Compared to Physiotherapy in Moderate Axial Spondyloarthritis (axSPA): a Randomized Controlled Multicenter Study.
Обзор
A few studies have evaluated the effectiveness of yoga therapy in patients with axial spondyloarthritis (axSPA). On the other hand, studies conducted in other chronic rheumatisms such as low back pain, rheumatoid arthritis or other conditions such as cancer have shown that yogatherapy can have a effective action on the physical and psychological level. Yogatherapy is a non-drug "body-mind" approach that would be likely to improve the physical symptoms (pain, stiffness, in particular spinal and pelvic), internal organs (colitis) and psychological symptoms as well as the perception of fatigue of people with axSPA. A 2021 study showed the feasibility and acceptability of regular yogatherapy practice in patients with axSPA. It is therefore necessary to conduct randomized controlled studies to assess the effectiveness of this management strategy.
Подробное описание
The term axial spondyloarthritis (axSPA) encompasses various inflammatory diseases of the spine, including ankylosing spondyloarthritis (AS) and non-radiographic axial spondyloarthritis (nr-axSPA).
axSPA is a chronic inflammatory joint disease affecting the axial skeleton. It is the second cause of chronic inflammatory rheumatism and affects 0.5 to 2% of the general population. It generally affects young adults, with a male predominance (2 men for 1 woman).
axSPA can lead to physical consequences (fatigue, pain, stiffness, with in particular serious damage to the spine causing functional impairment, etc.) and psychological consequences (anxiety, depression). It is responsible for a disability and a mediocre quality of life with, moreover, a significant socio-economic impact. In France, it is one of the long-term illnesses and may require heavy treatment.
The medicinal therapeutic side, taken care of by rheumatologists specializing in this pathology, has evolved a lot (from non-steroidal anti-inflammatory drugs \[NSAIDs\] to anti-tumor necrosis factor \[anti-TNF\] and anti-interleukin 17 \[anti-IL 17\]), allowing notable improvements. It is now a question of also developing the non-drug therapeutic side, to contribute to improving the quality of life, thus meeting the demand of patients with chronic diseases.
Information and therapeutic education occupy an important place, with results in favor of an improvement in the management of these diseases.
The recommendations emphasize that the non-pharmacological treatment of axSPA should include regular physical exercise, that individual and group physical therapy sessions should be considered as well as self-exercises.
Several randomized controlled trials have shown that physical therapy with various modalities has positive effects on pain and AS function. Physical therapy therefore also seems to play an important role in the management of patients. It prevents stiffness and improves functional capacity and quality of life.
Physical therapy should be initiated as soon as axSPA is diagnosed and regular exercise should form the basis of management. The review by Zochling et al. as well as a systematic review showed that exercises have positive effects on BASFI, BASDAI functions, pain and mobility. A Cochrane review on the role of physiotherapy interventions in SPA also concluded that physical therapy was beneficial. Physical activity, self-exercises and physiotherapy are part of the 2022 recommendations of the French Society of Rheumatology. Beneficial effects on disease activity were observed in axSPA, with good tolerance for intense exercise.
Recently an Indian team evaluated the effectiveness of online yogatherapy with 60 min structured modules on patients with axSPA for 3 months, with a significant improvement in the BASDAI score.
Вмешательства
- Процедура Yogatherapy
The experimental arm will benefit from support by a physiotherapist trained in yoga, in a group for ten weeks with two weekly sessions of approximately 1 hour each. A new yoga program adapted for the axSPA will be implemented. - Процедура Physiotherapy
The comparator arm will benefit from support by a physiotherapist, in groups for ten weeks at the rate of two weekly sessions of approximately 1 hour each. An already existing program adapted for the axSPA will be implemented.
Первичные конечные точки
- Evolution of the axSPA global activity score (fatigue, pain, stiffness) [Срок оценки: Between the 2 month visit and the 5 month visit.]
Вторичные конечные точки (12)
- Evolution of the axSPA global activity score (fatigue, pain, stiffness) [Срок оценки: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.]
- Functional impact [Срок оценки: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.]
- Health-related quality of life [Срок оценки: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.]
- Anxiety and depression [Срок оценки: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.]
- Respiratory capacity [Срок оценки: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.]
- Spinal and axial mobility (maximum active amplitudes - sagittal plane) [Срок оценки: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.]
- Spinal and axial mobility (degrees of kyphosis and lordosis) [Срок оценки: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.]
- Spinal and axial mobility (maximum active amplitudes - frontal plane) [Срок оценки: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.]
- Spinal and axial mobility (podobarometric treadmill) [Срок оценки: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.]
- Axial mobility [Срок оценки: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.]
- Follow-up of the therapeutic strategy [Срок оценки: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.]
- Drug consumption monitoring [Срок оценки: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.]
Критерии участия
Критерии включения
- French-speaking patient aged 18 and over
- Patient with axial spondyloarthritis (axSPA) according to Assessment of SpondyloArthritis International Society, diagnosed by a rheumatologist
- "Moderately active" to "active" form of axSPA (basic BASDAI \> 3)
- Stable disease: No recent or foreseeable introduction in the next 6 months of drug treatments for axSPA (excluding analgesics)
- Absence of disabling stress urinary incontinence
- Geographical or organizational possibility of undergoing the study
- Patient informed and having signed the informed consent form for participation in the research
Критерии исключения
- Pregnancy or breastfeeding
- Recent childbirth (within the last six months)
- Patient already practicing yoga or having practiced it in the last six months
- Abdominal or spinal surgery in the last six months
- Motor neurological deficit
- Sphincter deficit
- Any other somatic pathology preventing the practice of physiotherapy or yogatherapy according to the opinion of the evaluating clinician
- Depressive syndrome requiring specific treatment
- Non-affiliation to a social security scheme (beneficiary or beneficiary) or to another social protection scheme
- Patient deprived of liberty by judicial or administrative decision or under legal protection (guardianship, safeguard of justice)
- Currently participating in or in a period of exclusion from: another interventional research involving human participants, a clinical trial on a medical product for human, a clinical investigation on a medical device. Participation in non-interventional research is authorized.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Франция · 5 центров
- Hôpital Avicenne — Bobigny
- Hôpital Henri Mondor — Créteil
- Hôpital Henri Mondor — Créteil
- Hôpital Pitié Salpetrière — Paris
- Hôpital Cochin — Paris
Идентификаторы
NCT: NCT06083090 · APHP210998